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Editorial: Left to their own devices


Guess which segment of the healthcare industry gets what it wants on every issue it puts before Congress or the agency in charge of its regulation. Hint: It’s not the drug industry.

While every sector involved in delivering or insuring healthcare gets taxed to help pay for the insurance expansion under the Affordable Care Act, this subsector managed to wiggle out of its obligations.

In 2007, Congress asked this industry to label each of its products with a machine-readable identifier to promote safety, manage recalls and increase supply chain efficiency. More than a decade later, implementation still isn’t finished.

This industry’s failures can be life-threatening. Yet despite repeated outcries from physicians and patient advocates, it retains an approval process that absolves many of its most critical and expensive products from comprehensive clinical trial testing for safety and efficacy.

By now you recognize I’m talking about the medical-device industry. Led by a few Fortune 500 companies making implantable cardiovascular and orthopedic devices and expensive imaging equipment, it includes hundreds of small and midsize firms making everything from bedpans to surgical instruments.

Their geographic diffusion is often cited as the root of its power. Local representatives from both parties are susceptible to the industry’s grass-roots lobbying.

As a result, ideology plays almost no role in policymaking. When it comes to the device industry, the mantra “jobs, jobs, jobs” trumps safety and science. The Democratic senators from two of the more liberal states in the nation—Minnesota and Massachusetts—have consistently sided with two of the industry’s biggest devicemakers: Boston Scientific and Minneapolis-based Medtronic.

This month brought another awe-inspiring exercise of the industry’s enormous influence. Amid a government shutdown that has idled nearly a million Americans, including non-essential personnel at the Food and Drug Administration, that agency managed to put out regulatory guidance that will give devicemakers another pathway for skipping out on clinical trials on devices inserted into American patients.

It involves the 510(k) process, which grants easier FDA approvals for new devices that are deemed “substantially equivalent” to a device already FDA-approved. All you have to do is demonstrate through bench testing that it’s engineered in a similar fashion. No clinical trials required.

Examples of the disastrous medical consequences of this loophole include defibrillators with poorly designed electrical leads and unsafe surgical meshes. Johnson & Johnson has set aside $2.5 billion for patient lawsuits involving faulty hip implants approved through the 510(k) process, and, one day before the FDA announced its new guidance, agreed to pay $120 million to state attorneys general for making false claims about the devices’ safety.

Despite these notable failures, the FDA’s latest plan will allow manufacturers to skip already paltry bench tests in favor of an “appropriate performance criteria standard” that is “less burdensome” than the previous standard. It will be left up to FDA inspectors to develop performance criteria that are “at least as robust.”

In other words, not only will no clinical trials be required of these new follow-on devices, the company will be able to submit data showing its new device meets criteria that were created by FDA inspectors and company officials sitting in a room mulling over the possibilities.

Compare that to the hurdles put in the way of biosimilar manufacturer applications. Nearly every approval required safety and efficacy testing in more patients than had been tested in the trials leading to the approval of the innovator company’s original drug. Most included head-to-head comparison trials.

Bills aimed at curbing the drug industry’s pricing power are lining up for committee hearings like planes landing in Chicago after a snowstorm. It’s time for the relevant committees to tackle the regulation and prices of expensive and potentially dangerous devices, which are being inserted every day in thousands of patients in America’s hospitals.